Each g contains:

Yellow oral gel.

Please refer to the "Qualitative and quantitative composition" section.

Horses and ponies.

The veterinary medicinal product is indicated for treatment of infections caused by moxidectin sensitive strains of:

− Large strongyles:

. Strongylus vulgaris (adults and arterial stages)

. Strongylus edentatus (adults and visceral stages)

. Triodontophorus brevicauda (adults)

. Triodontophorus serratus (adults)

. Triodontophorus tenuicollis (adults)

− Small strongyles (adults and intraluminal larval stages):

. Cyathostomum spp.

. Cylicocyclus spp.

. Cylicostephanus spp.

. Cylicodontophorus spp.

. Gyalocephalus spp.

− Ascarids:

. Parascaris equorum (adult and larval stages)

− Other species:

The veterinary medicinal product has a persistent efficacy of two weeks against small strongyles. The excretion of small strongyles eggs is suppressed for 90 days.

The veterinary medicinal product is effective against (developing) intramucosal L4 stages of small strongyles. At 8 weeks after treatment, early (hypobiotic) EL3 stages of small strongyles are eliminated.

Do not administer to young foals less than 4 months.

Do not use in cases of hypersensitivity to the active substance or to any of the excipients or other milbemycins.

None.

To avoid overdosing, care should be taken to accurately dose foals, especially low bodyweight foals or pony foals.

Do not use the same syringe to treat more than one animal unless horses are running together or in direct contact with each other in the same premises. The veterinary medicinal product has been formulated specifically for use in horses only.

Avoid direct contact with skin and eyes.

Personal protective equipment consisting of protective gloves should be worn when handling the veterinary medicinal product.

Wash hands or any exposed area after use.

Do not smoke, drink or eat while handling the veterinary medicinal product.

In case of eye contact, flush the eye with copious amounts of clean water and seek medical advice immediately and show the package leaflet or the label to the physician.

Moxidectin fulfils the criteria for a (very) persistent, bioaccumulative and toxic (PBT) substance; therefore, exposure of the environment to moxidectin must be limited to the extent possible. Treatments should be administered only when necessary and should be based on faecal egg counts or evaluation of the risk of infestation at the animal and/or herd level. In order to reduce the emission of moxidectin to surface water and based on the excretion profile of moxidectin when administered as the oral formulation to horses, treated animals should not have access to watercourses during the first week after treatment.

Like other macrocyclic lactones, moxidectin has the potential to adversely affect non-target organisms:

∙ Faeces containing moxidectin excreted onto pasture by treated animals may temporarily reduce the abundance of dung feeding organisms. Following treatment of horses with the product, levels of moxidectin that are potentially toxic to dung beetles and flies may be excreted over a period of more than 1 week and may decrease dung fauna abundance.

Moxidectin is inherently toxic to aquatic organisms including fish. The product should be used only according to the label instructions.

The veterinary medicinal product has been formulated specifically for use in horses only. Dogs or cats may be adversely affected by the concentration of moxidectin in this veterinary medicinal product if they are allowed to ingest spilled paste or have access to used syringes. Neurological signs (such as ataxia, muscle tremor and convulsions) and digestive clinical signs (such as hypersalivation) were recorded.

Horses and ponies:

1 In young animals. These adverse effects are usually transient and disappear spontaneously in most cases.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

The veterinary medicinal product has been shown to be safe for use in pregnant and lactating mares.

None known.

Oral use.

Single administration of 400 µg moxidectin/kg bodyweight using the calibrated syringe.

Each syringe treats a 700 kg horse.

Bodyweight and dosage should be accurately determined prior to treatment. Underdosing could result in ineffective use and may favour resistance development.

Use of a scale or weight tape is recommended to ensure accurate dosing.

Before the first dose, hold the syringe with the capped end pointing to the left and so that you can see the weight measurements and tick marks (small black lines). Set the syringe to zero by moving the dial ring so the left side is set at the first full black mark and depress the plunger, safely discarding any paste that is expelled.

To dose the product, hold the syringe as previously described. Each tick mark relates to 25 kg of bodyweight and to 10 mg moxidectin. Turn the dial ring until the left side of the ring lines up with the weight of the animal.

Adverse reactions may occur at 2 times the recommended dose in foals and 3 times the recommended dose in adults. The symptoms are depression, inappetence, ataxia and flaccid lower lip in the 8 to 24 hours following treatment. Symptoms of moxidectin overdose are the same as those observed in very rare occasions at the recommended dosage. In addition, hypothermia and lack of appetite may occur. There is no specific antidote.

Not applicable.

Meat and offal: 32 days.

ATCvet code: QP54AB02

Moxidectin is a parasiticide active against a wide range of internal and external parasites and is a second-generation macrocyclic lactone of the milbemycin family. Moxidectin interacts with GABA and glutamate gated chloride channels. The net effect is to open the chloride channels on the postsynaptic junction to allow the inflow of chloride ions and induce an irreversible resting state. This results in flaccid paralysis and eventual death of parasites exposed to the drug.

The veterinary medicinal product is effective against benzimidazole resistant strains of cyathostomes.

Moxidectin is absorbed following oral administration with maximum blood concentrations being achieved 8 hours post application.

Bioavailability by the oral route is 40%. The drug is distributed throughout the body tissues but due to its lipophilicity it is selectively concentrated in the fat.

The elimination half-life is 28 days.

Moxidectin undergoes partial biotransformation by hydroxylation in the body and the only significant route of excretion is the faeces.

Moxidectin fulfils the criteria for a (very) persistent, bioaccumulative and toxic (PBT) substance. In particular, in acute and chronic toxicity studies with algae, crustaceans and fish, moxidectin showed toxicity to these organisms, yielding the following endpoints:

EC50: the concentration which results in 50% of the test species individuals being adversely affected, i.e. both mortality and sub-lethal effects.

NOEC: the concentration in the study at which no effects are observed.

This implies that when allowing moxidectin to enter water bodies, this may have a severe and lasting impact on aquatic life. To mitigate this risk, all precautions for use and disposal must be adhered to.

None known.

Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf-life after first opening the immediate packaging: 6 months.

Store below 25 °C.

High density polyethylene syringe containing 14,8 g of gel with a graduated plunger with a low-density polyethylene piston and cap packed as follows:

− Box containing one syringe.

− Box containing 10 individually boxed syringes.

− Box containing 20 syringes.

Not all pack sizes may be marketed.

Medicines should not be disposed of via wastewater.

The veterinary medicinal product should not enter water courses as moxidectin may be dangerous for fish and other aquatic organisms.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

Zoetis UK Limited

Vm 42058/5142

15 January 1999

August 2024

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.